Xeomin Receives New Indication
July 3, 2018 – The U.S. FDA has approved a new indication for Xeomin® (incobotulinumtoxinA), manufactured by Merz North America. The biologic is now indicated to treat chronic sialorrhea (excessive drooling) in adult patients. It is the first FDA-approved treatment for this indication.
Derived from botulinum toxin type A, Xeomin blocks nerve signals to a targeted area. The drug is delivered via intramuscular or intraglandular injection, depending on the indication. Recommended dosing to treat chronic sialorrhea is 100 Units per treatment session, consisting of 30 Units per parotid gland and 20 Units per submandibular gland, no sooner than every 16 weeks.
Chronic sialorrhea commonly affects individuals who have neurological disorders such as Parkinson’s disease, cerebral palsy, and amyotrophic lateral sclerosis (ALS). It can also occur in individuals who have suffered a stroke. Patients with chronic sialorrhea may have difficulty swallowing or controlling facial muscles, which impacts their ability to retain saliva inside of the mouth.
Xeomin originally received FDA approval in 2010 to treat cervical dystonia in adult patients, as well as blepharospasm in adult patients who had been previously treated with onabotulinumtoxinA. It carries an additional neurological indication to treat upper limb spasticity, and is available as a cosmetic treatment to reduce the appearance of frown lines between the eyebrows. Like other botulinum-toxin-derived products, Xeomin carries a black box warning that cautions its effects may spread beyond the target area hours to weeks after injection. This can result in difficulty swallowing and breathing, which can be fatal. These adverse effects are most prevalent in children, but adults may also be at risk, particularly if they are predisposed to these complications due to underlying medical conditions.
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- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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